Agency Approves Drug for Adult ADHD

Staff

8/19/2008

US Pharm.2008;33(8):23.

The FDA has broadened the indications for methylphenidate (Concerta) extended-release tablets in doses of 18 mg to 72 mg/day to include adults with attention-deficit hyperactivity disorder (ADHD). Methylphenidate was already approved for treatment of ADHD in children ages 6 to 18. Clinical trial data showed that the drug significantly improved ADHD symptoms such as inattention, impulsivity, and hyperactivity compared with placebo in patients aged 18 to 65.

The most common adverse reactions in adults were dry mouth, nausea, decreased appetite, headache, and insomnia.

Methylphenidate is contraindicated in patients with significant anxiety, tension, or agitation; glaucoma; tics; Tourette's syndrome (TS) or a family history of TS; current or past use of monoamine oxidase inhibitors; or narrowing of the esophagus, stomach, or intestine.

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